1. Fampridine; the slow-release formulation of 4-aminopyridine.
2. Teriflunomide; the active metabolite of lenflunomide.
3. Alemtuzumab; an oncology drug.
4. BG12; a modification of a drug for psoriasis
5. Ocrelizumab; a newer version of rituximab an oncology drug that also is licensed for rheumatoid arthritis.
6. Daclizumab; an earlier version of the drug was used in transplantation
7. Fingolimod; this was originally developed for the field of transplantation.
All these repurposed drugs are protected by patents, which prevents cheaper generic equivalents or biosimilars from entering the market for a pre-determined period of time. This is very important for the Pharma companies concerned as is allows them to get a return on investment and to make a profit.
Do you think these repurposed drugs are any cheaper than novel drugs?
A problem arises with the repurposing of drugs that are off patent; it is not possible to protect them from generic competition under the currently regulatory framework. For example, simvastatin, phenytoin, oxcarbazepine, amiloride and riluzole; all of these drugs are currently being tested in progressive MS.
I hope you can see why it is important to have a patent? A patent defines a period of market exclusivity, which allows the Pharma company, or organisation, a period of time to claw back their investment in the development programme of the drug and to pay for any post-marketing requirements that the regulators may ask for. For example, the latter may include a safety and pregnancy register.
What the Big Pharma Alternative is trying to address is the lack of incentives to repurpose off-patent drugs. How do we raise the necessary resources to test off-patent drugs in phase 3 and if positive to get them licensed for MS and to finance the post-marketing requirements that may come with a license? If we don’t address this problem we are unlikely to speed up drug development for progressive MS and we are going to have to discard several potentially effective drugs for progressive MS.”